DrSclafani answers some questions

A forum to discuss Chronic Cerebrospinal Venous Insufficiency and its relationship to Multiple Sclerosis.

IRB

Postby THEGREEKFROMTHED » Thu Jun 24, 2010 5:25 pm

DR S,
Welcome to the world of MS. One day youre on top and the next youre feeling like a kicked around piece of dung. (Relapse remit relapse remit) Don'f forget your roots. Caesar's infantry and cavalry was first rate, and he made heavy use of formidable ... engineering abilities and the legendary speed with which he maneuvered. Pick yourself up and dust yourself off. Nobody can maneuver like you (through veins) so get yourself a mortadella sandwich and a glass of Dago Red and take a well deserved breather. Then get back to your roots and get your legendary maneuverability back.

On another note. Have you figured out a way to fix that septum in my vertebral vein yet?
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Postby simone » Thu Jun 24, 2010 5:33 pm

drsclafani wrote:Ok
the IRB had many valid arguments and some arguments that revealed the inadequacy of my appliication. I did not make some points forcefully enough and thus they argued against my application because they thought the trial was for other purposes. For example i called my study a "safety and efficacy study". perhaps if i had stated it as a safety and observational study, they would have addressed it differently.

They made an excellent point about the patients being charged for the procedures, something most of you would have had no objection to. But if only those who can afford to pay were in the study, it would have meant that poor people would have been excluded and exclusion because of poverty would have gone against the priniciples of the Belmont Commission.

there are other points that i take exception to, but all in all, i do not think that they were intentionally biased as much as they were biased by the current publications which, other than zamboni, are lacking. It makes me quite unhappy that khan's opinion paper was accepted because of the weight of the journal it was published in.

Paolo has argued hard for publications and in a hurry. unfortunately without IRB approval, there isnt much to write

i am recovering


If you remedy their objections can you re apply?
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Postby MS_mama » Thu Jun 24, 2010 5:48 pm

drsclafani wrote:
one of the criticisms of dr zamboni's paper was that patients were on DMDs and thus there was no way to know whether any positive effects were due to dmd or liberation

it seems like even a randomized study of lib/no lib while on DMDs will leave that question dangling and diminish any for forcefullness of any improvements for liberationl


seems like a case of "damned if you do, damned if you don't" regarding studies with or without DMDs. I would guess it would be nearly impossible to get a large enough cohort of people not on DMDs and even then, the results would be attributed to "the variable nature of the disease."
dx RRMS Jun. 2009...on Copaxone and LDN and waiting for my turn to be "liberated"<br />
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Postby pklittle » Thu Jun 24, 2010 5:51 pm

nice vintage 1997 port would be ok



Dear Dr Sclafani,
Please PM me with info on where to send your vintage 97 port. :mrgreen:
I am serious!
Cheers,
Pam
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Postby MS_mama » Thu Jun 24, 2010 5:52 pm

drsclafani wrote:there are other points that i take exception to, but all in all, i do not think that they were intentionally biased as much as they were biased by the current publications which, other than zamboni, are lacking. It makes me quite unhappy that khan's opinion paper was accepted because of the weight of the journal it was published in.

Paolo has argued hard for publications and in a hurry. unfortunately without IRB approval, there isnt much to write


(don't even get me started on Dr.Khan....) in any case, I don't understand how science is supposed to move forward if, just because a few dr's research opposes an idea, others cannot come forward with their own studies to hash out the issues involved. It's not like there are major safety issues involved without stents being used.
dx RRMS Jun. 2009...on Copaxone and LDN and waiting for my turn to be "liberated"<br />
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Postby fogdweller » Thu Jun 24, 2010 6:30 pm

drsclafani wrote:Paolo has argued hard for publications and in a hurry. unfortunately without IRB approval, there isnt much to write


Withoput IRB approval, you can't publish. IRB won't grant approval since is very little published.

Hmm. seems a clasic catch 22. Aren't academic institutions supposed to encourage investigations into developing frontiers, not wait for others to blaxe the trail?
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Trial Design

Postby Shayk » Thu Jun 24, 2010 6:46 pm

Just a quick comment on the "randomized" trial design.

It's my impression lib/no lib may not fly. Lib or DMD might fly--I think there have been several papers questioning the "ethics" of no treatment in clinical trials given the availability of DMDs. A safety study would be first though I'd think.

Thanks so much Dr. S. --glad to learn you're in recovery mode. :)

Sharon
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Postby 1eye » Thu Jun 24, 2010 6:51 pm

OK,Doctor,

Let's all put our money where our mouths are.

Nobody minds paying, and a lot of people are willing to donate.

Let's make it count. There are 400 people a year in Canada who die with MS. John Robinson will soon be one of those if he doesn't get help soon. Write up a trial that speciifies as inclusion criteria that the patient has to be 9.9 on the EDSS. There must be 4000 in the US. This treatment has been shown to save lives. Put the donations on air ambulance service (bet you can get a package deal if you can't get volunteers). Tell the board you'll treat them for free if they will allow one patient from your waiting list to be treated for each humanitarian/trial case. Write up results after you have exactly duplicated Zamboni's results. Fill in the blanks after the same number have been done again. Have as inclusion criteria that there must be an equal number on and not on DMDs (this may rearrange the waiting list a bit, so maybe you specify must NOT beon DMDs.) Will they ever do a quick approval? Tell them time is of the essence. Maybe the MS Society would like to chip in for airfares. This really is life or death. Over 1 Canadian a day, and over 10 Americans a day. Tell them to think about that when they go to bed.
"Try - Just A Little Bit Harder" - Janis Joplin
CCSVI procedure Albany Aug 2010
'MS' is over - if you want it
Patients sans/without patience
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Postby ozarkcanoer » Thu Jun 24, 2010 7:39 pm

It seems to me that the BNAC study had to have SOME criteria regarding DMDs. We don't really know their reasoning for choosing people who are on DMDs only. They certainly wouldn't want a mix. They could have chosen people who are NOT on DMDs. I actually like the idea os choosing people on DMDs because if the people who get the procedure do better than the "sham" procedure then it will show the DMDs aren't all they are cracked up to be. Which many of us already know !

ozarkcanoer
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Postby Cece » Thu Jun 24, 2010 7:54 pm

drsclafani wrote:But if only those who can afford to pay were in the study, it would have meant that poor people would have been excluded and exclusion because of poverty would have gone against the priniciples of the Belmont Commission.

The Belmont Commission report:
http://ohsr.od.nih.gov/guidelines/belmont.html

It's section 3, the selection of subjects, where justice comes into play.

Dang it.
"However, the truth in science ultimately emerges, although sometimes it takes a very long time," Arthur Silverstein, Autoimmunity: A History of the Early Struggle for Recognition
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Postby drsclafani » Thu Jun 24, 2010 8:03 pm

simone wrote:
drsclafani wrote:Ok
the IRB had many valid arguments and some arguments that revealed the inadequacy of my appliication. I did not make some points forcefully enough and thus they argued against my application because they thought the trial was for other purposes. For example i called my study a "safety and efficacy study". perhaps if i had stated it as a safety and observational study, they would have addressed it differently.

They made an excellent point about the patients being charged for the procedures, something most of you would have had no objection to. But if only those who can afford to pay were in the study, it would have meant that poor people would have been excluded and exclusion because of poverty would have gone against the priniciples of the Belmont Commission.

there are other points that i take exception to, but all in all, i do not think that they were intentionally biased as much as they were biased by the current publications which, other than zamboni, are lacking. It makes me quite unhappy that khan's opinion paper was accepted because of the weight of the journal it was published in.

Paolo has argued hard for publications and in a hurry. unfortunately without IRB approval, there isnt much to write

i am recovering


If you remedy their objections can you re apply?


yes of course. their job is to review and assure privacy, patient rights, humanity and safety
but
pick your self up
dust your self off
and start all over again
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Postby drsclafani » Thu Jun 24, 2010 8:09 pm

Cece wrote:
drsclafani wrote:But if only those who can afford to pay were in the study, it would have meant that poor people would have been excluded and exclusion because of poverty would have gone against the priniciples of the Belmont Commission.

The Belmont Commission report:
http://ohsr.od.nih.gov/guidelines/belmont.html

It's section 3, the selection of subjects, where justice comes into play.

Dang it.


and that is one of the reasons i said i was sorry

I blew it. I was more concerned about poor people as subjects being unjust, not about people who could afford as subject

price will be a concern. So to meet their concerns, i might need financial support to allow people without financial means equal opportunity
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Postby SoberSandy » Thu Jun 24, 2010 8:11 pm

Dr. Sclafani: Thank you for all the work you have done for the MS community. We love your dedication, your principles and your prioities. Actually, we love you. I have been sitting here quietly reading, following along. But now I must break my silence. I am facing a scary possibility which I am trying to prevent. My wonderful husband, John Robinson has very advanced MS. He is paralyzed, eats through a tube and relys on a vent through the night. Due to chronic fatigue he sleeps most of the day. Since hearing about the Liberation Treatment last year, it has been his wish to be treated. He hopes to gain enough strength to stay awake through the day and to prevent getting anymore infections. His bigger hopes are to live without the vent (do all of his own breathing) and live without the feeding tube (eat real food). He has a positive outlook and deeply cares for everyone he meets. He even still has a great sense of humor. He is well loved and has two children. We are doing everything we can to get testing and treatment for John but despite our best efforts this has not been arranged as yet. Please Dr. Sclafani is there anything you can do to help us reach our goal? We have started a letter writing campaign and I have contacted my local newspaper. Today was a scary doy. John had a mucus plug and could not breathe. I worked with the RT for an hour and we finally got his oxygen saturation and heart rate back to normal. It feels like we are running out of time. Anything you can do would be greatfully appreciated.
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Postby drsclafani » Thu Jun 24, 2010 8:13 pm

ozarkcanoer wrote:It seems to me that the BNAC study had to have SOME criteria regarding DMDs. We don't really know their reasoning for choosing people who are on DMDs only. They certainly wouldn't want a mix. They could have chosen people who are NOT on DMDs. I actually like the idea os choosing people on DMDs because if the people who get the procedure do better than the "sham" procedure then it will show the DMDs aren't all they are cracked up to be. Which many of us already know !

ozarkcanoer


ozarkcanoer, it is a confounding variable. the question of whether the DMDs have impact will make it more difficult to prove that liberation is valuable.
Also consider, suppose DMDs have deliterious effects upon liberation.

Eventually, there will have to be a trial that compares drug therapy to liberation to determine whether DMDs are useful or necessary after liberation

but first .....
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Postby drsclafani » Thu Jun 24, 2010 8:21 pm

adamt wrote:Dear Dr Sclafani,

My doctor who will be doing my phlebography (and if shown CCSVI then balloon angiplasty) , she will be pewrforming the procedure this Friday.


In our consultation she said only 50% of the numerous MS patients she has liberated with balloons, have seen symptom improvement.
The other 50% that she liberates with balloon angio , have No changes!

Now this is worrying me as i am due to have the plebography on Friday and treatment if necessary. But i dont want to go through all of this to have No changes.


Do you have any form of liberation balloon angio protocol i could show her? as she has not been trained by dr zamboni but is a vascular surgeon.

What percentage of your patients that are liberated with balloon angio, see symptom improvement?

Any help would be appreciated Doctor

Thank you

Adam


that is about right.

however ask her to give you a break down by MS classification. RRMS better than SPMS better than PPMS
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